Study: PrEP safe for use by teenage gay and bisexual boys
With regular adherence, Truvada is as safe and effective among adolescent MSM as among adult MSM
Images via CDC.gov and FDA.gov
A new study finds that pre-exposure prophylaxis, in the form of a single pill, taken regularly, can protect against HIV infection in adolescent males who have sex with other males, reports Reuters.
The single pill, produced by pharmaceutical giant Gilead and more commonly known by its moniker Truvada, is a combination of emtricitabine and tenofovir disproxil fumarate. It has been used as a form of PrEP over the past five years, and was shown to reduce the risk of HIV infection among at-risk populations by over 90 percent.
But the new study, published in the Journal of the American Medical Association is one of the first to look at the medication’s effects on adolescent boys who are undergoing or have recently undergone puberty.
As part of the study, researchers studied 78 gay and bisexual young men from ages 15 to 17, from six U.S. cities. All participants tested negative for HIV at the start of the study. They received a counsing session about HIV risk, plus daily doses of PrEP for the next 48 weeks.
Forty-seven participants successfully completed the study. The medication was generally well tolerated, with only three adverse events or reactions that were possibly related to PrEP, the researchers found.
Sybil Hosek, the lead author of the study, who serves as a clinical psychologist and HIV researcher at Cook County Health and Hospitals System’s Stroger Hospital in Chicago, told Reuters that she hopes the new data will be submitted to the Food & Drug Administration. The FDA will then have to consider whether to approve the use of the pill among adolescent boys, just as birth control has been approved for use by adolescent girls.
“I do hope clinicians increase their comfort with being able to provide PrEP to adolescents,” Hosek said.
Another key finding from the study was that researchers did not see an increase in sexually risky behaviors by participants, an argument that has previously been raised as an objection to prescribing PrEP.
In total, three participants became infected with HIV, but blood samples suggest they were taking less than two doses of PrEP each week when they were infected. The current recommendation for all patients, regardless of age, is that PrEP be taken on a daily basis.
The rate of HIV infection was 6.4 cases per 100 people per year, twice as high as the rate among men ages 18 to 22 enrolled in a similar trial, but Hosek largely attributes that to lack of adherence and the tendency of adolescents to miss doses.
“I shudder to think what the rate would be if we didn’t offer PrEP,” she told Reuters.
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